The eJuices.co team is hard at work helping your business succeed. Part of that work is unraveling and breaking down the latest news regarding regulations and legislation of the vape industry. Recently, manufacturers, retailers, and other stakeholders have been in the dark regarding how the vape industry will be regulated after PMTA. Here’s what we know so far.
What We Know So Far
As you already should know, the PMTA deadline has passed on September 9, 2020. Information on specific enforcement actions and actual enforcement actions are still scarce, but we do know that the FDA is targeting products that can be potentially marketed to minors, as well as the targeting of disposable vape products.
The Deeming Rule has stated that any vape product on the market prior to August 8, 2016 has to submit a PMTA application beyond the September 9 date. Most have submitted PMTA applications, while some manufacturers have only submitted some of their products, and others have chosen not to go through the process due to costs or other reasons such as additional red tape.
What This Means For The Vape Industry
Senator Dick Durbin (D-IL), a longtime opponent of the vaping industry, has demanded that the FDA release the PMTA list. He said, “It has been more than one month since PMTA applications were submitted to the FDA. In order to protect public health and uphold the duty to enforce against products on the market that are out of compliance, I urge the FDA to immediately publish a comprehensive product listing of all relevant e-cigarette applications received by the FDA.”
FDA Center for Tobacco Products Mitch Zeller has said that the agency intends to publish a list of products that are going through the PMTA process. However, Zeller did not disclose when such a list would be available. You can currently check out if products have gone through PMTA (or not) through VapePMTA. Knowing Durbin’s record on vape, the eJuices.co team speculates that Durbin is attempting to force the FDA’s hand to carry out actual enforcement, even though manufacturers, retailers, and wholesalers like eJuices.co are still unsure of the final decision from the FDA regarding the PMTA list.
Retailers have urged the publication of the PMTA list as well, so they can be informed of what can be sold and what couldn’t be sold in their stores. “The PMTA list will be critical to support compliance across the tobacco trade channel, helping inform distributors, wholesalers, and retailers which ENDS products are being marketed legally in accordance with FDA’s compliance policy. Relatedly, such a list also would facilitate enforcement against those manufacturers that continue to introduce illegally marketed products without premarket authorization or, in the case of deemed, currently marketed products, without a PMTA submitted by the deadline,” said a group of retailers headed by the National Association of Convenience Stores (NACS).
The eJuices.co team will update you as new information becomes available. We encourage you to speak with your eJuices.co account manager or sales representative if you have any questions or concerns. We look forward to working with you and helping your business succeed, especially at a time where information on regulation and legislation is critical to the success of your business.